SMITH & NEPHEW, INC. GII SLT 3 MOD TIB CUTBLCK RT; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
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Model Number 71440205 |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/03/2021 |
Event Type
malfunction
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Event Description
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It was reported that, during setup or inspection it was noticed that these instruments showed an overabundance of bio-film that has built up on the instruments over the years.No case reported; therefore, there was no patient involvement.
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Manufacturer Narrative
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The associated device, intended for use in treatment, was returned for evaluation.A visual inspection of the returned device confirmed the stated failure mode.The device is heavily contaminated.The device shows signs of extensive use.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.We recommended cleaning method given in our cleaning and sterilization brochure ¿recommendations for decontamination and sterilization of smith & nephew orthopedic devices.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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